Epi-On Corneal Crosslinking for Keratoconus

Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a
candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked
to participate in this study and will undergo the required screening procedures to determine
study eligibility. Informed consent will be obtained from each subject before performance of
any required any required study procedures that are not part of the investigator's routine
examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day),
then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and
measurements of best spectacle-corrected visual acuity will be obtained and baseline and at
appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the
study will include observations at appropriate times for adverse events, clinically
significant findings on ophthalmic examination, and slit-lamp examination.

The primary efficacy parameter is the change from baseline over time in maximum keratometry
(K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and
best corrected visual acuity (BCVA).

Inclusion Criteria:

- 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed
consent, willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

- Previous ocular condition (other than refractive error) in the eye(s) to be treated
that may predispose the eye for future complications (herpes simplex/zoster, recurrent
corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to
become pregnant, or lactation during study. Corneal pachymetry <350 microns at the
thinnest point measured by Pentacam in the eye(s) to be treated.

Nystagmus or any other condition that would prevent steady gaze. Other systemic condition
that in the investigator's opinion would not allow the patient to be a good candidate for
the study.